European Pharmaceutical Review

FEBRUARY 12, 2024

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

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Process Improvement Packaging 98

ISPE

OCTOBER 27, 2022

Towards Next Generation Antisense Oligonucleotides: Mesylphosphoramidate Modification Improves Therapeutic Index and Duration of Effect of Gapmer Antisense Oligonucleotides.” 16 (20 September 2021): 9026–41. “Oligonucleotide Therapeutics: From Discovery and Development to Patentability.” Pharmaceutics 14, no. 2 (February 2022): 260.

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Process Improvement Packaging Compounding Dosage 98

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 14–25 (November–December 2021). 25 February 2021. BioProcess International 8 December 2021 (November–December 2021) [link] 23 Bio-Process Systems Alliance. 14 Whitford, W.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

MARCH 29, 2023

Published 15 November 2021. The authors propose using Module 2.3 to effectively convey the control strategy and clearly identify the established conditions (ECs) or regulatory binding elements that “are considered necessary to assure product quality and therefore would require a regulatory submission if changed post approval.”

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 15 November 2021. The authors propose using Module 2.3 to effectively convey the control strategy and clearly identify the established conditions (ECs) or regulatory binding elements that “are considered necessary to assure product quality and therefore would require a regulatory submission if changed post approval.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Journal of Pharmaceutical Sciences (2021). 2021.09.046.

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Documentation FDA Communication Packaging 52

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Yet in 2021, 100 nanomedicines had been marketed. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing.

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Process Improvement Packaging Vaccines FDA 95